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Barr Receives Approval for Generic Glucophage(R) XR Extended-Release Tablets, 750 mg.

Company Awarded 180 Days of Generic Exclusivity

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market a generic version of Bristol Myers Squibb's Glucophage(R) XR (metformin hydrochloride extended-release tablets) 750 mg. The FDA's approval letter awarded Barr 180 days of generic exclusivity under the provisions of Hatch-Waxman. The Company launched its generic product earlier today.

Barr filed an Abbreviated New Drug Application (ANDA) for metformin hydrochloride extended-release tablets, 750 mg that contained a challenge to the patent listed in the Orange Book for Glucophage XR. Bristol Myers Squibb subsequently listed an additional patent in the Orange Book. Barr amended its ANDA to contain a challenge to that additional patent. Bristol Myers Squibb did not bring suit against Barr within the 45-day period provided for by the Hatch-Waxman Act on either of the listed patents.

Glucophage XR (metformin hydrochloride extended-release tablets), as a monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes in patients 17 years of age and older. Glucophage XR, 750 mg had annual sales of approximately $25 million for the twelve months ended July 2004, based on IMS data.

Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.

CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720,

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Publication:PR Newswire
Geographic Code:1USA
Date:Oct 18, 2004
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